Optimisation Strategy for Emergency Tracheal Intubation

NCT05539391 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Bordeaux

Phase

Not applicable

Started

2023-01-14

Last updated

2025-09-24

Condition(s) studied

EmergenciesOut-of-hospital SettingTracheal Intubation

Investigational drug(s) / intervention(s)

Data patientPhysical examinationRapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEBRapid sequence intubation (RSI) : Recommendations for emergency intubation

Data patient: Medical History and characteristic of patient

Physical examination: Arterial pressure, arterial oxygen saturation, heart rate

Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB: Rapid sequence intubation (RSI) will be performed with use of rocuronium as paralytic agent (1.2 mg/ kg). Bag-mask ventilation between induction and laryngoscopy will be performed. The GEB will be systematically used at the first attempt to facilitate intubation.

Rapid sequence intubation (RSI) : Recommendations for emergency intubation: Rapid sequence intubation (RSI) using succinylcholine as a paralytic agent (1 mg/kg), no systematic bag-mask ventilation between induction and laryngoscopy, use of GEB to facilitate intubation in case of intubation failure under direct laryngoscopy.

Study summary

This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient adult (≥ 18 years) presenting with vital distress requiring emergency tracheal intubation as assessed by the emergency physician in the out-of-hospital setting. * Patient with all conditions (trauma, dyspnea, coma, overdoses, and shock) except those in cardiac arrest will be included. Exclusion Criteria: * Patient presenting of a contraindication to succinylcholine, and/or rocuronium, and/or sugammadex (rocunorium antagonist). * Patient who have contraindication to bag face mask ventilation before intubation (ongoing emesis, hematemesis, or hemoptysis). * Patient that are not members of a medical aid scheme (beneficiary or main member). * Patient under specific protection measures: pregnant, parturient or nursing women; legal protection or deprived of liberty: patient under judicial protection, patient under guardianship/curatorship.

Primary outcome measure(s)

Severe intubation-related complications occurring during the first hour after intubation — Day 0
Proportion of patients with severe intubation-related complications occurring during the first hour after intubation The severe intubation-related complications are: * Cardiac arrest. * At least one arterial hypotension episode defined by systolic blood pressure\<90 mmHg. * At least one hypoxemia episode defined by an occurrence of a new episode of oxygen. * Saturation \< 90%. * Severe cardiac arrhythmia: ventricular tachycardia. * Pulmonary aspiration, reported by the physician. * Esophageal intubation. * Unintentional extubation. Severe intubation-related complications will be recorded by the emergency physician in charge of the patient.

Trial sites (22)

Facility	City	Region	Status
CHU d'Angers	Angers	France	Recruiting
CH Carnelle Portes de l'Oise	Beaumont-sur-Oise	France	Recruiting
AP-HP - Hôpital Avicenne	Bobigny	France	Recruiting
CHU de Bordeaux - Hôpital Pellegrin	Bordeaux	France	Recruiting
CH de Pontoise René Dubos	Cergy-Pontoise	France	Recruiting
AP-HP - Hôpital Henri Mondor	Créteil	France	Recruiting
CHU de Dijon	Dijon	France	Not Yet Recruiting
GH Eaubonne Montmorency Hôpital Simone VEIL	Eaubonne	France	Recruiting
AP-HP - Hôpital Raymond Poincaré	Garches	France	Recruiting
CHU de Grenoble - Hôpital Nord La Tronche	La Tronche	France	Recruiting
CH de Versailles - Site André Mignot	Le Chesnay	France	Not Yet Recruiting
HCL - Hôpital Edouard Herriot	Lyon	France	Recruiting
GH Sud Ile de France	Melun	France	Recruiting
CHU de Montpellier Site Lapeyronie	Montpellier	France	Recruiting
CHU de Nantes - Hôpital Hôtel Dieu	Nantes	France	Recruiting
AP-HP - Hôpital Lariboisière	Paris	France	Recruiting
AP-HP - Hôpital Pitié-Salpétrière	Paris	France	Recruiting
AP-HP - Hôpital Necker	Paris	France	Recruiting
CHU Poitiers - Hôpital la Milétrie	Poitiers	France	Recruiting
CHU de la Réunion - site Sud	Saint-Pierre	France	Recruiting
GH Sélestat Obernai	Sélestat	France	Not Yet Recruiting
CHU Toulouse - Hôpital Purpan	Toulouse	France	Recruiting

More University Hospital, Bordeaux trials in France

Biobank and Brain Health in Bordeaux. Recruiting

Evaluation of the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity. Starting soon

Development of a Prediction Score for the Occurrence of Death or Lung Transplantation in Patients With Emphysema Secondary to Alpha-1-anti-tripsin Deficiency Recruiting

Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Valves: a Prospective Randomized Open-label Multicentric Trial Enriched With Historic Controls. Starting soon

Validation of the Proteomic Profiling as a Diagnostic Test for Extra-hepatic Cholangiocarcinoma Starting soon

Other trials for the same condition

Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ? Recruiting

Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults Recruiting

Quality of Life and Persistent Pain 3 Months After Emergency Surgery Before and After a National Urgency Classification Active, not recruiting

Nebulized Fentanyl in Healthy Volunteers Recruiting

Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05539391 on ClinicalTrials.gov ↗ ← All trials in France